Introduction to Phase III track with Beth Ludwig

Authors: Ludwig EA
Conference: SLP MIDD+
Keywords: clinical pharmacology, MIDD, MIDD (model-informed drug development), modeling and simulation, Phase III, SLP MIDD+ Virtual Conference, SLP2021MIDD
Division: DILIsym Services

Beth Ludwig, Associate Vice President, Quantitative Clinical Pharmacology, gives a brief introduction to the application of Modeling & Simulation in Phase 3 – questions to be addressed, speakers, and presentations.​

  • Do the intended dose(s) demonstrate the desired safety and efficacy in the population?​
  • ​Is the dose likely to change in a given subpopulation or special population? If so, by how much?

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Presented at SLP MIDD+ Virtual Conference March 3-4, 2021